“It’s actually probably more common than you would think that industry and FDA disagree on whether a new 510(k) is needed or not,” says Brad Thompson, a member of Epstein Becker & Green in the healthcare and life sciences practice and a member of MD+DI’s editorial advisory board. …

“The problem is, over the years, there’s been a fairly significant shift in the way FDA wants to draw that line,” Thompson says, referring to the line determining when a modification necessitates a 510(k) submission.